Leaked files slam stem-cell therapy

Alison Abbott in Nature:

NatureA series of damning documents seen by Nature expose deep concerns over the safety and efficacy of the controversial stem-cell therapy promoted by Italy’s Stamina Foundation. The leaked papers reveal the true nature of the processes involved, long withheld by Stamina’s president, Davide Vannoni. Other disclosures show that the successes claimed by Stamina for its treatments have been over-stated. And, in an unexpected twist, top Italian scientists are dissociating themselves from an influential Miami-based clinician over his apparent support for the foundation. Stamina, based in Brescia, claims that it successfully treated more than 80 patients, mostly children, for a wide range of conditions, from Parkinson’s disease to muscular dystrophy, before the health authorities halted its operations in August 2012. A clinical trial to assess the treatment formally was approved by the Italian government last May, and an expert committee was convened by the health ministry to study Stamina’s method and to recommend which illnesses the trial should target.

Stamina says that its technique involves extracting mesenchymal stem cells from a patient’s bone marrow, culturing them so that they turn into nerve cells, and then injecting them back into the same patient. But full details of the method have never been revealed, and Vannoni provided the full protocol to the expert committee only in August. In October, the committee’s report prompted health minister Beatrice Lorenzin to halt plans for the clinical trial. That led to public protests in support of Stamina, and, after an appeal by Vannoni, a court ruled in early December that the expert committee was unlawfully biased. Some members had previously expressed negative opinions of the method, the ruling said. As a result, Lorenzin appointed a new committee on 28 December, reopening the possibility of a clinical trial.

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